Metadate ER, Methylin ER, and Ritalin SR: Duration of action is approximately 8 hr; may use in place of methylphenidate IR tablets when 8-hr dosage of methylphenidate ER and SR tablets corresponds to the titrated 8-hour dosage of methylphenidate IR; not to exceed 60 mg/day

QuilliChew ER (chewable extended-release tablets): 20 mg PO qAM initially; may be titrated up or down weekly in increments of 10 mg, 15 mg or 20 mg, not to exceed 60 mg/day

Jornay PM: Initial, 20 mg PO qDay in the evening; may titrate weekly in increments of 20 mg; not to exceed 100 mg/day; initiate dosing at 8:00 p.m.; adjust timing of administration between 6:30 pm and 9:30 pm to optimize tolerability and efficacy the next morning and throughout the day

Metadate ER, Methylin ER, and Ritalin SR: Duration of action is approximately 8 hr; may use in place of methylphenidate IR tablets when 8-hr dosage of methylphenidate ER and SR tablets corresponds to the titrated 8-hr dosage of methylphenidate IR

Metadate ER, Methylin ER, and Ritalin SR: May be given in place of immediate-release products once the daily dose is titrated and the titrated 8-hour dosage corresponds to SR or ER tablet size; not to exceed 60 mg/day

Metadate ER, Methylin ER, and Ritalin SR: May be given in place of immediate-release products once the daily dose is titrated and the titrated 8-hour dosage corresponds to SR or ER tablet size; not to exceed 60 mg/day

Cautions

Use caution in hypertension (monitor)

Stimulants used to treat ADHD are associated with serious cardiovascular events including sudden death, stroke, and MI; avoid in patients with structural cardiac abnormalities or other serious heart problems

Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud phenomenon; may improve with dose reduction or discontinuation

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment

Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation

Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients

Aggressive behavior or hostility is often observed in children and adolescents with ADHD; monitor for the appearance of or worsening of aggressive behavior or hostility

Monitor growth during treatment of children with stimulants; may need to interrupt therapy in patients not growing or gaining weight as expected

Stimulants may lower convulsive threshold in patients with prior history of seizure, patients with prior EEG abnormalities in absence of seizures, and very rarely, patients without a history of seizures and no prior EEG evidence of seizures; discontinue therapy in the presence of seizures

Use with caution in patients who use other sympathomimetic drugs

Amphetamines may exacerbate motor and phonic tics and Tourette’s syndrome; perform clinical evaluation for tics and Tourette’s syndrome in children and their families prior to treating with stimulant medications

Rare instances of prolonged and sometimes painful erections (priapism), sometimes requiring surgical intervention, reported with methylphenidate products; typically not reported during initiation, but often subsequent to an increase in dose; seek immediate medical attention for abnormally sustained or frequent and painful erections

Do not use Concerta with pre-existing severe gastrointestinal narrowing conditions, including esophageal motility disorders, cystic fibrosis, history of peritonitis, small bowel disease, or chronic intestinal pseudo-obstruction, or Meckel's diverticulum

Transdermal patch

Chemical leukoderma (permanent loss of skin pigmentation) may occur at and around application site; loss of pigmentation, in some cases, has been reported at other sites distant from the application site; patients or their caregivers should watch for new areas of lighter skin, especially under the drug patch, and immediately report these changes to their health care professional; discontinue therapy if it occurs

Acts faster on inflamed skin

Use of transdermal methylphenidate may lead to contact sensitization; discontinue treatment if contact sensitization is suspected; erythema is commonly seen with use of transdermal methylphenidate and is not by itself an indication of sensitization; suspect sensitization if erythema is accompanied by evidence of a more intense local reaction, like edema, papules, and vesicles and do not significantly improve within 48 hr or spreads beyond patch site

Avoid exposing application site to direct external heat sources; heat applied after patch application, increases both the rate and extent of absorption

Pregnancy & Lactation

Pregnancy

A pregnancy exposure registry monitors pregnancy outcomes in women exposed to JORNAY PM during pregnancy; healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388

Published studies and postmarketing reports on methylphenidate use during pregnancy are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes; no teratogenic effects were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 2 and 9 times the maximum recommended human dose (MRHD) of 100 mg/day given to adolescents on a mg/m2 basis, respectively; however, spina bifida was observed in rabbits at a dose 31 times the MRHD given to adolescents; a decrease in pup body weight was observed in a pre-and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 3.5 times the MRHD given to adolescents

CNS stimulant medications can cause vasoconstriction and thereby decrease placental perfusion; no fetal and/or neonatal adverse reactions reported with use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers

Lactation

Limited published literature, based on breast milk sampling from five mothers, reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7

There are no reports of adverse effects on breastfed infant and no effects on milk production; however, long-term neurodevelopmental effects on infants from CNS stimulant exposure are unknown; consider developmental and health benefits of breastfeeding along with the mother's clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

Do not remove the tablet from the blister pack until just prior to dosing

Remove tablet by peeling back foil on blister pack; do not push the tablet through the foil

Do not store tablet for future use

Administer immediately after opening by placing the tablet on the patient’s tongue and letting it dissolve; do not chew or crush

Tablet will disintegrate in saliva so that it can be swallowed; no liquid is needed to take the tablet

Jornay PM

Not to be administered in the morning

Following determination of optimal administration time, advise patients to maintain a consistent dosing time

Advise patients to take the dose consistently either with or without food

May take capsule whole, or may be opened and the entire contents sprinkled onto applesauce; if patient is using the sprinkled administration method, the sprinkled applesauce should be consumed immediately and not stored and should be taken in its entirety without chewing; the dose of a single capsule should not be divided and should be taken at the same time

Periodically reevaluate longterm use and adjust dosage as needed

Missed dose

Take dose as soon as patient remembers that same evening; if patient remembers the missed dose the following morning, skip the missed dose and wait until next scheduled evening administration

Switching from other methylphenidate products

If switching from other methylphenidate products, discontinue that treatment, and titrate with Jornay PM using the titration schedule described above

Do not substitute for other methylphenidate products on an mg-per-mg basis, because of different methylphenidate base compositions and differing pharmacokinetic profiles

Transdermal system (Daytrana): Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F); store in protective pouch; once tray is opened, use patches within 2 months; once an individual patch has been removed from the pouch,use immediately; do not refrigerate or freeze

Manage and view all your plans together – even plans in different states.

Compare formulary status to other drugs in the same class.

Access your plan list on any device – mobile or desktop.

The above information is provided for general
informational and educational purposes only. Individual plans may vary
and formulary information changes. Contact the applicable plan
provider for the most current information.

View explanations for tiers and
restrictions

Tier

Description

1

This drug is available at the lowest co-pay. Most
commonly, these are generic drugs.

2

This drug is available at a middle level co-pay. Most
commonly, these are "preferred" (on formulary) brand drugs.

3

This drug is available at a higher level co-pay. Most
commonly, these are "non-preferred" brand drugs.

4

This drug is available at a higher level co-pay. Most
commonly, these are "non-preferred" brand drugs or specialty
prescription products.

5

This drug is available at a higher level co-pay. Most
commonly, these are "non-preferred" brand drugs or specialty
prescription products.

6

This drug is available at a higher level co-pay. Most
commonly, these are "non-preferred" brand drugs or specialty
prescription products.

NC

NOT COVERED – Drugs that are not
covered by the plan.

Code

Definition

PA

Prior Authorization Drugs that
require prior authorization. This restriction requires that
specific clinical criteria be met prior to the approval of the
prescription.

QL

Quantity Limits Drugs that
have quantity limits associated with each prescription. This
restriction typically limits the quantity of the drug that will
be covered.

ST

Step Therapy Drugs that have
step therapy associated with each prescription. This restriction
typically requires that certain criteria be met prior to
approval for the prescription.

OR

Other Restrictions Drugs that
have restrictions other than prior authorization, quantity
limits, and step therapy associated with each prescription.